FDA.reportPublic FDA data

NDC 0067-7918-01 - Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0067-7918
Requested NDC
0067-7918-01
Package NDCs from labels
0067-7918-01, 0067-7918-06
Manufacturer
Haleon US Holdings LLC
Effective date
2024-04-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
THERAFLU MULTI-SYMPTOM SEVERE COLD - Haleon US Holdings LLCHaleon US Holdings LLC2024-04-10HUMAN OTC DRUG LABEL
THERAFLU NIGHTTIME SEVERE COLD AND COUGH - Haleon US Holdings LLCHaleon US Holdings LLC2024-01-28HUMAN OTC DRUG LABEL
Theraflu Nighttime Severe Cold and Cough - Select CorporationSelect Corporation2022-05-04HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-7918-01THERAFLUNIGHTTIME SEVERE COLD AND COUGH237 mL in 1 PACKETPOWDER, FOR SOLUTION23712
0067-7918-06THERAFLUNIGHTTIME SEVERE COLD AND COUGH6 in 1 CARTONPOWDER, FOR SOLUTION612
0067-7918-01Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough237 mL in 1 PACKETPOWDER, FOR SOLUTION1422 mL650 mg in 237mL8
0067-7918-01Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough237 mL in 1 PACKETPOWDER, FOR SOLUTION1422 mL650 mg in 237mL8
0067-7918-06Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough6 in 1 CARTONPOWDER, FOR SOLUTION650 mg in 237mL8
0067-7918-06Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough6 in 1 CARTONPOWDER, FOR SOLUTION650 mg in 237mL8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-7918THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC]12Current NDC, Legacy NDC, 2 package rows20240129_5f7f6f70-0f36-4541-89f2-d953259cdb1e.zip
0067-7918THERAFLU MULTI-SYMPTOM SEVERE COLD AND THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC]8Current NDC, Legacy NDC20240411_b06b64c5-dbb4-4ef5-af18-3d7d4979c02f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-7918-01EA - Each0067-791853abe691-ab9e-417e-83a4-f095d2857a7512022-06-06
0067-7918-06EA - Each0067-7918bd024597-3a48-4bb9-a8d1-15d200f87b9512014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTHERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]3
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTHERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTHERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MTHERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTHERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]3
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTHERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]3
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTHERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTHERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATHERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]3
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTHERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTHERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]3
SUCROSEINACTIVE INGREDIENTC151H8M554THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]3
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 57 of 360 · 7,193 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PMS Relief Maximum StrengthACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATECVS Pharmacy760ee367-0625-48d7-98a7-84c69389ad3e2026-05-12WarningsExact identifier
unii: 362O9ITL9D
Sinus Pressure and Pain Daytime Nighttime Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company3cac44ad-1835-487e-b6d0-1483d724bb5e2026-05-12WarningsExact identifier
application number: M012
Menstrual ReliefACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATETarget Corporationbc65e205-64fd-4764-8c5e-2793af4e9adf2026-05-12WarningsExact identifier
unii: 362O9ITL9D
GUAIFENESIN DMGUAIFENESIN AND DEXTROMETHORPHANCardinal Health 107, LLC9cfb1abb-98c4-4e90-8dd7-fcffc112f9882026-05-12WarningsExact identifier
application number: M012
good sense naproxen sodiumDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUML. Perrigo Companyf548aa3d-b35e-458a-9815-3595a451ab782026-05-11WarningsExact identifier
unii: TC2D6JAD40
Sleep Aid NighttimeDIPHENHYDRAMINE HCLCVS Pharmacy0be4ef9a-2484-41dd-8bb8-e92d411f13842026-05-11WarningsExact identifier
unii: TC2D6JAD40
Nasal Decongestant PE and Pain Relief Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLWinCo Foods, LLCfab51b36-1c2e-4c97-932c-dacfaf55935a2026-05-11WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
up and up 12 hour cough reliefDEXTROMETHORPHAN POLISTIREXTarget Corporationa8acec73-dc66-444e-9438-370893cd51292026-05-11WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINWalgreen Companycad5da8c-65a6-44c4-a4c7-38f2c7fe43aa2026-05-11WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Market Basket Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDemoulas Super Markets, Inc.e15439c7-0e3c-7752-e053-2995a90a1a402026-05-11WarningsExact identifier
unii: XF417D3PSL
Meijer Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEMeijer Distribution Inc7305972b-aa0f-4daa-e053-2991aa0adfd72026-05-11WarningsExact identifier
unii: XF417D3PSL
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
application number: M012
Nighttime Sleep-AidDIPHENHYDRAMINE HCLAMERISOURCE BERGENca052b38-de38-7bf0-e053-2995a90a4e852026-05-11WarningsExact identifier
unii: TC2D6JAD40
Genexa Kids Pain and FeverACETAMINOPHENGenexa, Inc.091dd1e7-2484-cdbf-e063-6394a90a21892026-05-11WarningsExact identifier
unii: 362O9ITL9D
Device - NebuClear MD Hand-held Rubber Bulb NebulizerDEVICE - HAND-HELD RUBBER BULB NEBULIZERBlue Echo Care LLC43e0a646-be57-1024-e063-6394a90a43e42026-05-11WarningsExact identifier
application number: M012
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED1efd1778-7ab1-4797-98c5-4637940ee3ec2026-05-11WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Little Remedies Infant Fever/Pain RelieverACETAMINOPHENMedtech Products Inc.af5c3b3b-079f-4ee6-a9a4-a13ee8cd99a52026-05-11WarningsExact identifier
unii: 362O9ITL9D
Multi-Symptom PMS ReliefACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED81ef39e2-b91e-4d34-b594-4ba557cc319b2026-05-11WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACYafacdc0b-fb65-464e-91b8-e82ba7ecde442026-05-11WarningsExact identifier
unii: 362O9ITL9D
DRMITSUI MEDICAL HAEMORRHOIDPHENYLEPHRINE HCI WITCH HAZELYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED51720221-893b-cade-e063-6394a90adaec2026-05-10WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.